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Cardiac Operation Under Totally Endoscope and Cardiopulmonary Bypass (CPB)

Cardiac Operation Under Totally Endoscope and Cardiopulmonary Bypass, a Single Center's Experience

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00921596
Acronym
CPB
Enrollment
800
Registered
2009-06-16
Start date
2000-01-31
Completion date
2009-12-31
Last updated
2009-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Defects, Heart Valve Diseases

Keywords

Surgical Procedures, Cardiac, Minimally Invasive Surgical Procedures, Thoracoscopes, Cardiopulmonary Bypass

Brief summary

Conventional cardiac operations are performed with median sternotomy, which is related to great wound, morbidities, longer duration in hospital and most significantly, cosmetic problems. The investigators invested a new minimally invasive cardiac operation method totally under video-endoscope and peripheral cardiopulmonary bypass. The investigators' hypothesis is that this new minimally method could provide better cosmetic effects to the patients, and also relate to shorter postoperative hospital stay and better recovery.

Interventions

PROCEDUREcardiac operation with totally endoscopic method

Cardiac operations are performed with three keyholes in the right chest wall. Video images are obtained by digital thoracoscope through one hole. Intracardiac lesions are accessed with surgical instruments and repaired through the other two holes. Cardiopulmonary bypass is set up with femoral cannulations. Moderate system hypothermic is applied for the operation. Cardiac arrest is achieved with ascending aorta clamp and cardioplegia solution delivery through aortic root cannulation. After the intracardiac lesions are repaired, aortic clamp is removed, and the heart is reperfused to restore its spontaneous rhythm. After the patients are rewarmed to normal temperature, CPB is discontinued. Femoral cannulations are removed, and surgical wounds are closed.

Sponsors

Xijing Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* congenital heart defects or heart valve diseases require surgical correction

Exclusion criteria

* Body weight \< 10kg * committed with complex congenital heart defect * anticipated to perform aortic valve repair or replacement * anticipated to perform aorta repair or replacement * committed with Femoral vessel diseases unable to perform femoral cannulation * refuse to perform totally thoracoscope minimally invasive surgery

Design outcomes

Primary

MeasureTime frame
all cause mortalityone year

Secondary

MeasureTime frame
all cause morbidityone year

Countries

China

Contacts

Primary ContactZhenxiao Jin, MD
jinzx10262@yahoo.com.cn86-29-84771022
Backup ContactXuezeng Xu, MD
xuxuez@fmmu.edu.cn86-29-84775312

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026